Future Prospects of CLINICAL RESEARCH in Pakistan
The Significance of TRAININGS & Professional Development – Indispensable for Global Compliance and Career Advancement
Date of Event: Saturday, August 23, 2014
Venue: Liaquat National Hospital & Medical College, Karachi
Time: 11:00am – 01:00pm
Panel of Speakers:
v Dr Ahson Siddiqui, Chief Scientific Officer, Novartis Pakistan
v Dr Obaid Ali, Federal Inspector, Drug Regulatory Authority of Pakistan
v Mr. Faisal H. Roohi, Director Clinical Research and Operations, Metrics Research, Pvt Ltd
Hosted by: Liaquat National Hospital and Medical College, Karachi
A short one day introductory program took place at the capacious Liaquat National Hospital and Medical College Auditorium, Karachi to generate awareness about clinical research and training with emphasis on the following topics:
- An Introduction to the Clinical Research and Inspections in Pakistan
- Importance of Phamacovigilance and Safety
- Certified Clinical Research Professional (CCRP) Course Introduction
The prime objective of this informative event as with similar events in the past and events planned for the future was to generate awareness among clinical, medical and life science professionals about the formidable opportunities available to Pakistan for the promotion of international clinical research projects.
Secondly, the need for specialized trainings that caters the specific needs of the growing clinical research business such as adherence with global standards known as the international conference on Harmonization and Good Clinical Practice (ICH GCP) that provide the necessary knowledge base for the conduct of international clinical research to the participating clinical research staff and investigators.
Most importantly Metrics wishes to bridge the stakeholders – Pharma, local heath authority, Drug Regulatory Authority of Pakistan (DRAP), hospitals, institutions, ethics review boards, clinical and life sciences professionals, M/O Labor and Manpower, Trade Development Authority and other vested interests on a common platform for devising a clinical research initiative in the interest of promotion of R&D, better understanding on etiology and management/ controls of diseases endemic to Pakistan. Clinical trials and epidemiologic studies will allow evaluation of suburban and rural regions where health threats are prevalent in Pakistan.
Pakistan has the necessary infrastructure, talented HR, regulatory department, ethics boards, patient pool and wherewithal to attract international pharmaceutical, biotechnology companies, research institutions’ including NGO’s to conduct sound and cost effective research in collaboration /or through partnerships thereby combating the local and global health threats and challenges in a concerted and synergistic manner.
Need for Pharmacovigilance and Safety Monitoring
Dr Ahson Siddiqui, Chief Scientific Officer at Novartis, a seasoned expert with a wealth of experience on safety made a memorable presentation. Having worked in government, Pharma and as a practicing physician he enthralled the audience highlighting the significance of pharmacovigilance in this century sharing a brief historical narrative of what all can go wrong in drug development and how major disasters such as the thalidomide disaster leading to malformed children can be avoided and prevented from happening ever again.
Dr. Ahson mentioned that drug development is a continuous process from its inception as molecule to post-marketing surveillance as drugs are now closely monitored for safety. Blockbuster drug Vioxx would not have been withdrawn were it not for close monitoring and vigilance. Pharmacovigilance monitoring is critical in clinical research to assure only the safest drug reach the pharmacy shelves. He said Pakistan’s DRAP needs to come forward and plan layouts for pharmacovigilance monitoring system its implementation in accordance with international standards.
Finally, Dr Ahson replied to a volley of questions from the audience and expressed his appreciation for ongoing clinical research training programs in Pakistan.
Importance of Clinical Research and Inspections
Dr. Obaid Ali, Federal Inspector with Drug Regulatory Authority of Pakistan (DRAP) apprised the audience about the relevance and importance of clinical research in Pakistan due to the width and scope of clinical research business globally. He appreciated Liaquat National Hospital and Metrics Research’s efforts to generate clinical research awareness and provide trainings.
Inspections being his focus of interest and expertise generated significant interest especially in respect to tainted drugs, identifying patients, pharmacies and identifying the ‘culprit’ manufacturing company.
He thanked the organizers and assured that he would be willing to present at the next event to track Liaquat National Hospital and Metrics Research’s progress in clinical research awareness campaigns and professional training programs in Pakistan. He felt the need to market Pakistani clinical research potential thereby funneling much needed revenue to the national exchequer and secondly that certified and qualified professionals can bring laurels to the country by virtue of his or her excellence.
Introduction to Clinical Research Trainings
Introduction to clinical research professional certificate programs and the advantages thereof in the S. Asian region were emphatically elaborated upon in poignant detail by Mr. Faisal. He shared with the audience the history of Kriger Research Group International’s (KRGI) foundation, its international presence in 4 continents to disseminate the knowledge of Good Clinical Practices (GCP) allowing emerging market economies (EME’s) partake of international global clinical R&D pie with a net worth of several billion dollars in drug discovery alone.
Focused courses offering specialized trainings in clinical research with immediate practical involvement due to a dearth of qualified clinical research professionals across the globe offer a lucrative and rewarding career option for graduates with clinical, life sciences, pharmacy and nursing backgrounds in particular. Irrespective of the impending global economic downturn, demand for talent in this vocation remains unabated. Clinical research professionals assume management roles such as that of clinical research associates, clinical research coordinators, data managers, clinical quality assurance officers and auditors with roles in industry and regulatory bodies in particular.
The allure of participation in breakthrough research projects such as gene therapy, targeted medicines, and novel devices employing nanotechnology – Many of which may be global multicenter projects with roles such as project management, site selection and study initiation, monitoring, supervising, analyzing/evaluating, resolving queries, generating reports and most importantly communicating with peers around the world for a common objective introducing the next blockbuster drug is exciting to say the least.
India and China in Asia have taken a whopping lead in the Asia-Pac region breaking geographical boundaries by offering their countries for research as viable alternatives to the cost containment measures spiraling out of control in US and EU nations and secondly search for eligible patient pools.
Pakistan too has the right mix – Decent tertiary care hospitals, treatment naive patients, talented HR, and a research friendly regulatory department to name a few.
It is about time Pakistan too joined the bandwagon of clinical research nations as it is an opportunity right at our doorstep, begging to happen in Pakistan.
Future Prospect of Clinical Research (Post event notes)
Mr. Faisal H Roohi, Director Clinical Research and Operations at Metrics Research – the first contract clinical research and site management organization (CRO & SMO) of Pakistan was profound in his account about the veritable possibilities of clinical research business as a major and significant booster to modernize the existing healthcare infrastructure. Pakistan has been tied to an agrarian based economy for greater part of 60 years. He contrasted and compared the HR and revenue generated by the cotton industry of Pakistan to that of one major global CRO. Approximately ten thousand employees at Quintiles (Global CRO) generate revenues to the tune of USD 4 billion whereas 360,000 employer engaged in the cotton industry of Pakistan generate USD 9 billion.
ClinicalTrials.gov is a registry of federally and privately funded clinical trials conducted in USA and around the world – Currently, 173,801 studies are listed in the database from 50 states and 161 countries.
All together there are 274 Phase II, III and IV studies listed for Pakistan.
THE PHARMACEUTICAL MARKET:
- The pharmaceutical market will reach nearly USD 1,200 billion by 2016.
- The research-based pharmaceutical industry currently spends over USD 135 billion on R&D per year.
- Leading emerging countries will account for 28% of global spending on pharmaceuticals by 2015, compared to 12% in 2005.
- The US share will decline from 41% in 2005 to 31% in 2015, while Europe’s share will fall from 27% in 2005 to 19% in 2015.
This speaks volumes about the need for international collaborations and to promote Pakistan clinical research profile and preparedness.
It was opportune to also share some of Pakistan’s research capacity and capability landmarks:
- Potential Surplus Population in Working Age Group (2020) = 19m (2nd only to India)
- Incidence of cancer in Pakistan is >800,000 / annum
- The population of Pakistan has been reported to have the highest rate of breast cancer of any Asian population
- 90,000 breast cancer cases annually. Recessively inherited genes may contribute to breast and ovarian cancer risk in Pakistan
- CV Disease – #1 health threat (26.9%). One in 4 middle-aged adults in Pakistan has prevalent coronary arterial diseases
- Diabetics – to be ranked 4th in the world in 2010 (currently 12% in Pakistan)
- Liver Diseases pandemic – 2.5 million people are infected with the hepatitis B and C viruses (6% with Hep C alone)
Mr. Faisal’s presentation raised eyebrows as very few people among the audience were truly aware of the real potential of clinical research as an avenue for the progress of not only the health infrastructure, but also gainful employment opportunities for the research starved graduates of the clinical and life sciences institutions of higher learning.
Mr. Faisal lauded Liaquat National Hospital’s foresight by forging an agreement with Metrics Research in the trainings realm, which is bearing fruit.
Award Ceremony for Successful Certified Clinical Research Professionals
The first batch of 20 successful graduates of the certified clinical research professional (CCRP) development program was awarded certificates through Kriger Research Group International of Canada by the honorable guests, Dr Ahson Siddiqui and Dr Obaid Ali.
Pakistan’s Clinical Research Potential
The next preferred sought after destination for conducting clinical trials ought to be Pakistan. The reasons are plain to see and logical, with relaxed government regulations, dedicated regulatory authority, sound infrastructure, availability of large number of private hospitals, treatment naïve patients, a talented pool of internationally trained physicians and talented clinical staff (primarily EU and US) who adhere to international conventions such as ICH GCP guidelines via compliance training.
Pakistan’s strategic location will enable it to efficiently initiate and monitor trials nationwide and regionally (particularly the CentralAsianRepublics).
There is tremendous potential for Phase II – IV clinical trials involving all therapeutic areas, especially Hematology/ Oncology, Cardiovascular disease and Diabetes (incidence ranked 7th in the world) studies.
Chronic diseases (cardiovascular disease, diabetes, chronic lung diseases, and cancer) are among the top 10 causes of morbidity and mortality and account for approximately 25% of total deaths (2,3). Thirty-three percent of the adult population older than 45 years has high blood pressure; 10% of the adult population older than 18 years has diabetes, and more than 54% of men use tobacco. Data from an unselected autopsy series have shown coronary artery involvement (of greater than 50% luminal diameter reduction) in more than 24% of those studied. Moreover, the coastal metropolis of Karachi, with a population of more than 15 million, reports one of the highest incidences of breast cancer for any Asian population (4-9).
What gives Pakistan the necessary edge over other countries in conducting Clinical Trials Research?
• A large diverse population (incl. treatment naïve patients and heterogeneous gene pool)
• Availability of evaluable patients in numerous therapeutic categories
• Fast pace of recruitment
• Low cost in conducting clinical trials
• A willing population eager to participate in novel drug therapies
• A government that supports and encourages induction of trials
• English cultural and colonial influence with English as the co-official language and business language of the country
• GCP compliant sites committed to upholding international conventions and ethical standards
• Lack of regulatory hurdles due to an increasingly accommodating regulatory environment
• Relaxed duties and taxes on import of test articles and supplies
• Pakistan’s highly talented English speaking workforce
• Extremely labor and investment friendly environment of Pakistan
• Low manpower costs
• High quality of service
• Best infrastructure
5 Key Reasons to Invest In Pakistan
The current struggle with installing democratic values in a preeminently feudal and traditional society with colonial influence exacted a human and financial toll as evident in the media columns. But, with decent state institutions and deep rooted state apparatus, this initial struggle bodes well for a robust economy and progressive society ahead.
Reason – 1: Geostrategic Location
Located in the heart of Asia, Pakistan is the gateway to the energy rich Central Asian States, the financially liquid Gulf States and the economically advanced Far Eastern tigers. This strategic advantage alone makes Pakistan a marketplace teeming with possibilities.
Reason – 2: Trained and Talented Workforce
English is the official language and primary means of communication at businesses and educational setups
Reason – 3: Economic Outlook
Pakistan had one of the fastest growing economies of the world having touched a GDP growth rate of 8.4% in 2005. Today Pakistan has 170 million consumers with an ever growing middle class. Foreign investment had risen sharply from an average of $400 million in the 1990s to over $ 3.5 billion in 2005-06. Fiscal deficit had declined from an average 7% of GDP in the 1990s to around 3% in recent years. And FOREX reserves had increased from $3.22 billion in 2000-1 to $13.14 billion in 2005-6.
Reason – 4: Investment Policies
Current investment policies have been tailor made to suit investor needs. Pakistan’s policy trends have been consistent, with liberalization, de-regulation, Privatization, and facilitation being its foremost cornerstones.
Reason – 5: Financial Markets
The capital markets are being modernized, and reforms have resulted in development of infrastructure in the stock exchanges of the country. The Securities and Exchange Commission has improved the regulatory environment of the stock exchanges, corporate bond market and the leasing sector. Whilst the Central Board of Revenue has facilitated structural reform in tax and tariffs and the State Bank of Pakistan has invigorated the banking sector into high returns on investment.